EN
CAUTIONS
1.
Have a suitable backup system readily available for immediate use so the procedure
can be continued if a malfunction should occur.
2.
US federal law restricts this device for sale only by, or on the order of, a physician.
3.
Keep aView dry during preparation, use and storage.
4.
Pay attention to the battery symbol indicator on the aView monitor. Recharge aView
when the battery level is low (see section 4.1). It is recommended that aView is
recharged before every procedure and that a charger be readily available during use.
5.
Place or hang the aView monitor on a stable support while in use. Dropping aView
could damage it.
6.
Position the power cord where it is unlikely to be stepped on. Do not place any objects
on the power cord.
7.
aView is not intended to be repaired. If defect aView shall be discarded.
8.
The batteries in aView are not changeable and must only be removed upon disposal.
2. System Description
The aView monitor can be connected with a range of Ambu visualisation devices (cf. section 2.2
for compatible devices) to display the video image from an Ambu visualisation device. The aView
monitor is reusable. No modification of this equipment is allowed.
Ambu® aView™
Part numbers:
Bracket
Part numbers:
405002000
Model no.
JANUS2-W08-R10
(SW versions v2.XX)
405017700
For aView model no., please check backside label on aView.
aView is not available in all countries. Please contact your local sales office.
Power supplies
Part numbers:
x5
aView power supply
manufacturer:
FSP Group Inc.
aView power supply part
number: FSP030-REAM
EU/CH 405014700X
(not DK & UK)
UK 405013700X
DK 405012700X
AUS & NZ
405015700X
US 405016700X
Accessories
Part numbers:
aView adaptor
cable for composite
connection
405000712
2.2. Compatible Devices
The compatible Ambu visualisation devices for aView are:
Green connection port (see “5a” on page 2) :
Blue connection port (see “5b” on page 2):
- Ambu® aScope™ 2
- Ambu® aScope™ 3 Family
- Ambu® aScope™ 4 Broncho Family
Only one visualization device can be connected to aView at a time. aScope 2, aScope 3 Family and aScope 4
Broncho Family are not available in all countries. Please contact your local sales office.
(e.g. for attaching
the aView to an I.V. pole)
1. Important Information – Read Before Use
Read these safety instructions carefully before using the aView monitor. The Instruction for Use
may be updated without further notice. Copies of the current version are available upon request.
Please be aware that these instructions do not explain or discuss clinical procedures. They
describe only the basic operation and precautions related to the operation of the aView monitor.
1.1. Intended Use
The aView
TM
monitor is a non-sterile, reusable digital monitor, intended to display live imaging
data from Ambu visualisation devices.
1.2. Warnings and Cautions
Failure to observe these warnings and cautions may result in patient injury or damage to
the equipment.
Ambu is not responsible for any damage to the system or patient injury
resulting from incorrect use.
WARNINGS
1.
aView images must not be used as an independent diagnostic of any pathology.
Physicians must interpret and substantiate any finding by other means and in the light
of the patient's clinical characteristics.
2.
Do not use the aView monitor if it is damaged in any way or if any part of the functional
check fails.
3.
The aView is not to be used when delivering highly flammable anaesthetic gases to the
patient. This could potentially cause patient injury.
4.
The aView is not to be used in a MRI environment.
5.
Do not use aView during defibrillation.
6.
When handling the patient do not simultaneously touch the aView power socket or
docking connector.
7.
Always watch the live endoscopic image on the aView when advancing or withdrawing
a visualization device.
8.
To avoid risk of electric shock, this equipment must only be connected to a supply
mains with protective earth. To disconnect aView from mains remove the mains plug
from the wall outlet.
9.
Clean and disinfect the aView monitor after each use according to the instructions in
section 5. Disconnect aView from any mains power supply, remove any accessories and
make sure the aView is completely turned off before cleaning and disinfection.
10. Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
11. Electronic equipment and the aView may affect the normal function of each other.
If the aView is used adjacent to or stacked with other equipment, observe and verify
normal operation of both the aView and the other electronic equipment prior to using
it. It may be necessary to adopt procedures for mitigation, such as reorientation or
relocation of the equipment or shielding of the room in which it is used. Consult the
tables in appendix 1 for guidance in placing aView.
12. Be careful to check whether the image on the screen is a live image or a recorded
image and verify that the orientation of the image is as expected.
13. Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of
the system, including cables specified by the manufacturer. Otherwise, degradation of
the performance of this equipment could result.
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